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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Software medical device, used with a Philips Interventional X-Ray System. Provides navigation support for cardiovascular devices for heart rhythm disorders.
Philips Medical Systems Nederland B.V.
EP navigator - 5
In Commercial Distribution

  • 00884838059184 ()
000071

  • Angiographic x-ray system application software
Digital image acquisition system designed to automate patient work flow that includes image processing algorithms for imaging.
VAREX IMAGING CORPORATION
v4.9
In Commercial Distribution

  • 00854344007658 ()


  • Angiographic x-ray system application software
No Description
CORTECHS LABS INC
NQ BT
In Commercial Distribution

  • 00860000004824 ()


  • MRI system application software
No Description
Novadaq Technologies Inc
SQ3500
In Commercial Distribution

  • 00858701006018 ()


  • Angiographic x-ray system application software
The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system.
TrackX Technology, LLC
ASC PROCEDURE KIT 1
In Commercial Distribution

  • 00857088008769 ()
980-3TX

  • Diagnostic x-ray digital imaging system workstation application software
The device is a general surgical instrument: a non-sterile, reusable T-Handle instrument, with a Hudson-style quick-connect.
TrackX Technology, LLC
TrackX Hudson T-Handle
In Commercial Distribution

  • 00857088008752 ()
1003-3TX

  • Diagnostic x-ray digital imaging system workstation application software
TrackX reusable adapter that enables physicians to calibrate retractors with a distal blade diameter of 26mm with the Calibrator 2.0.
TrackX Technology, LLC
ACCESS-CALIBRATOR CUP 2
In Commercial Distribution

  • 00857088008745 ()
304-3TX

  • Diagnostic x-ray digital imaging system workstation application software
The device consists of a sterile Array component that mates with an INSIGHT Base component to create a unique SNAP that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. The INSIGHT™ ARRAY-VIOLET when assembled with an INSIGHT Base is designed to mount onto the shaft of a cylindrical instrument.
TrackX Technology, LLC
INSIGHT™ ARRAY-VIOLET
In Commercial Distribution

  • 00857088008714 ()
703-3TX

  • Diagnostic x-ray digital imaging system workstation application software
TrackX reusable adapter that enables physicians to more adequately utilize the INSIGHT BASE FLEX-25 SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX PE ADAPT - MJF VS
In Commercial Distribution

  • 00857088008677 ()
TX-3-4121

  • Diagnostic x-ray digital imaging system workstation application software
TrackX reusable adapter that enables physicians to more adequately utilize the Insight Base - NV/AT Disc Prep SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX NV INSERT-ADAPT
In Commercial Distribution

  • 00857088008660 ()
TX-3-4089

  • Diagnostic x-ray digital imaging system workstation application software
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